Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Relugolix 120 mg Tablets: Patients will receive a loading dose of 360 mg (3 tablets of Relugolix 120 mg) on day 1. From day 2, patients will take 1 tablet of Relugolix 120 mg daily till
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patient will be included if all the inclusion criteria listed below are met: 1. Male patients aged greater than or equal to 18 years who agree to provide written informed consent 2. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate 3. Patient is a candidate for, in the opinion of the investigator, at least 6 months of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer 4. Has a serum testosterone at the Screening and randomization visit of greater than or equal to 150 ng/dL 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at initial screening and at baseline 6. Is a male patient who, even if surgically sterilized, agrees to use a male condom if having sex with a woman of childbearing potential or a pregnant woman, during the entire study Treatment Period and for at least 2 weeks after last treatment dose
Exclusion criteria
Exclusion criteria: Patient will be excluded if any disease specific or study specific exclusion criteria listed below are met: 1. In the investigators opinion, is likely to require chemotherapy or surgical therapy for disease management within 6 months of initiating study drug 2. Previously received gonadotropin-releasing hormone analogue or other form of androgen deprivation therapy (estrogen or antiandrogen) for greater than 18 months total duration. If androgen deprivation therapy was received for lesser than or equal to 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot 3. Previous systemic cytotoxic treatment for prostate cancer 4. Patients with suspected Brain metastasis based on clinical evaluation 5. History of surgical castration 6. Have following laboratory values at screening • Serum ALT and/or AST greater than 2 ULN • Total bilirubin greater than ULN • Serum creatinine greater than 2.0 mg/dL • Platelets less than 100 x 1000 /µL • Hemoglobin less than 10.0 g/dL • Leukocytes (WBC) less than 3 x 1000 /µL • Absolute neutrophil count less than 1.5 x 1000/µL 7. Previous treatment with Relugolix. 8. Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance of relugolix, including inability to swallow whole tablets 9. Any other medical or psychiatric condition or laboratory examination finding that, in the opinion of the investigator, would interfere with accomplishing the study objectives or the patient completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Sustained castration rate defined as proportion of patients achieving and maintaining serum testosterone at castrate level (lesser than 50ng/dL) by week 4 through 24 weeks of treatmentTimepoint: Day 29 to Day 169 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Castration rate defined as proportion of patients achieving serum testosterone lesser than 50ng/dL.Timepoint: Day 4, Day 8 (week 1) and Day 15 (week 2);2. Profound castration rate defined as proportion of patients achieving serum testosterone lesser than 20ng/dLTimepoint: Day 15 (week 2);3. Sustained Profound castration rate defined as proportion of patients achieving and maintaining serum testosterone suppression of lesser than 20 ng/dL by Week 4 through 24 weeks of treatmentTimepoint: [Day 29 to Day 169].;4. PSA response rateTimepoint: Day 15 (week 2), Day 29 (week 4), Day 57 (week 8), Day 85 (week 12), Day 113 (week 16), Day 141 (week 20), Day 169 (week 24) | — |
Countries
India
Contacts
Public ContactDr Rajiv Yadav
Sun Pharma Laboratories Limited
Outcome results
None listed